Implantable medical device having a sleeve

ABSTRACT

Implantable medical devices are described. For example, various implantable medical devices having a sleeve with differential wall thicknesses are described. An exemplary medical device comprises a frame and a sleeve that has a first configuration where the sleeve is in an extended position and a second configuration where the sleeve is in an inverted position.

FIELD

The disclosure relates generally to medical devices. More particularly,the disclosure relates to implantable medical devices having a sleeve.

BACKGROUND

Minimally invasive techniques and instruments for placement ofintraluminal medical devices have developed over recent years. A widevariety of treatment devices that utilize minimally invasive technologyhave been developed and include stents, stent grafts, occlusion devices,infusion catheters and the like. Stents—frame-like structures placedwithin a body vessel to provide support to and maintain patency of thevessel—became especially popular with the introduction of coronarystents to the U.S. market in the early 1990s. Since that time, bothcoronary and peripheral stents have been proven to provide a superiormeans of maintaining vessel patency, and have become widely accepted inthe medical community.

The use of stents has been extended to treatments that target other bodyvessels. For example, bile duct stents, ureter stents, and esophagealstents are now widely used to maintain patency of each of these bodilypassages. Esophageal stents, for example, are sometimes used to maintainpatency of the esophagus from a point within the vessel, such as in thetreatment of a stricture that threatens closure of this vessel.

Stenting of the esophagus provides unique challenges not faced by stentsintended for other vessels, such as vessels of the vasculature. Forexample, the lower esophageal sphincter—a muscle near the junction withthe stomach—is normally closed to block stomach acid from entering theesophagus. Normally, this muscle only opens during swallowing to allowfood to pass into the stomach. After a stent is placed across thismuscle, however, the sphincter can remain open in response to theintraluminal support provided by the stent, reducing the ability of themuscle to block acid entry into the esophagus. Over time, acid passageinto the esophagus can cause tissue damage, aspiration pneumonia, andother undesirable outcomes.

Thus, a need exists for improved medical devices for modifying the flowof material and/or fluid through a bodily passage.

SUMMARY

Various exemplary intraluminal medical devices are described.

A first exemplary intraluminal medical device comprises an expandableframe and a sleeve. The expandable frame has a first frame end and asecond frame end and defines a frame lumen that extends from the firstframe end to the second frame end. The sleeve is attached to the frameand has a first sleeve end, a second sleeve end, an inner surface, anouter surface, a first portion, a second portion, a circumferentiallength, and an axial length. The sleeve defines a sleeve lumen thatextends between the first sleeve end and the second sleeve end and theaxial length of the sleeve extends from the first sleeve end to thesecond sleeve end. The first portion extends along a portion of thecircumferential length and a portion of the axial length from the firstsleeve end towards the second sleeve end. The first portion has a firstwall thickness that extends between the inner surface and the outersurface. The second portion extends along a portion of thecircumferential length and a portion of the axial length from the secondsleeve end towards the first sleeve end. The second portion has a secondwall thickness that extends between the inner surface and the outersurface. The first wall thickness is greater than the second wallthickness. The sleeve is adapted to invert between an extended positionin which the second sleeve end and a part of the first portion isdisposed outside of the frame lumen and an inverted position in whichthe second sleeve end and the part of the first portion is disposedwithin the frame lumen.

A second exemplary intraluminal medical device comprises an expandableframe and a sleeve. The expandable frame has a first frame end and asecond frame end and defines a frame lumen that extends from the firstframe end to the second frame end. The sleeve has a first sleeve endattached to the frame, a second sleeve end, an inner surface, an outersurface, a first portion, a second portion, a circumferential length,and an axial length. The sleeve defines a sleeve lumen that extendsbetween the first sleeve end and the second sleeve end and the axiallength of the sleeve extends from the first sleeve end to the secondsleeve end. The first portion extends along a portion of thecircumferential length and a portion of the axial length from the firstsleeve end towards the second sleeve end. The first portion has a firstwall thickness that extends between the inner surface and the outersurface. The second portion extends along a portion of thecircumferential length and a portion of the axial length from the secondsleeve end towards the first sleeve end. The second portion has a secondwall thickness that extends between the inner surface and the outersurface. The first wall thickness is greater than the second wallthickness and the sleeve defines a taper between the first sleeve endand the second sleeve end along a portion of the axial length. Thesleeve is adapted to invert between an extended position in which thesecond sleeve end and a part of the first portion is disposed outside ofthe frame lumen and an inverted position in which the second sleeve endand the part of the first portion is disposed within the frame lumen.

A third exemplary intraluminal medical device comprises an expandableframe and a sleeve. The expandable frame has a first frame end and asecond frame end and defines a frame lumen that extends from the firstframe end to the second frame end. The sleeve has a first sleeve endattached to the frame, a second sleeve end, an inner surface, an outersurface, a first portion, a second portion, a circumferential length,and an axial length. The sleeve defines a sleeve lumen that extendsbetween the first sleeve end and the second sleeve end and the axiallength of the sleeve extends from the first sleeve end to the secondsleeve end. The first portion extends along the entire circumferentiallength and a portion of the axial length from the first sleeve endtowards the second sleeve end. The first portion has a first wallthickness that extends between the inner surface and the outer surface.The second portion extends along the entire circumferential length and aportion of the axial length from the second sleeve end towards the firstsleeve end. The second portion has a second wall thickness that extendsbetween the inner surface and the outer surface. The first wallthickness is greater than the second wall thickness and the sleevedefines a continuous taper between the first sleeve end and the secondsleeve end. The sleeve is adapted to invert between an extended positionin which the second sleeve end and a part of the first portion isdisposed outside of the frame lumen and an inverted position in whichthe second sleeve end and the part of the first portion is disposedwithin the frame lumen.

Additional understanding of the exemplary medical devices can beobtained by review of the detailed description, below, and the appendeddrawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a side view of a first exemplary intraluminal medical device.The intraluminal medical device is shown in a first configuration.

FIG. 1A is a sectional view of a first portion of the sleeve of theintraluminal medical device illustrated in FIG. 1.

FIG. 1B is a sectional view of a second portion of the sleeve of theintraluminal medical device illustrated in FIG. 1.

FIG. 1C is a sectional view of the intraluminal medical deviceillustrated in FIG. 1, taken along line 1C-1C.

FIG. 2 is a side view of the first exemplary intraluminal medical devicein a second configuration.

FIG. 3 is a side view of a second exemplary intraluminal medical device.The intraluminal medical device is shown in a first configuration.

FIG. 3A is a sectional view of the intraluminal medical deviceillustrated in FIG. 3, taken along line 3A-3A.

FIG. 3B is a sectional view of the intraluminal medical deviceillustrated in FIG. 3, taken along line 3B-3B.

FIG. 4 is a side view of the second exemplary intraluminal medicaldevice in a second configuration.

FIG. 5 is a side view of a third exemplary intraluminal medical device.The intraluminal medical device is shown in a first configuration.

FIG. 5A is a sectional view of the intraluminal medical deviceillustrated in FIG. 5, taken along line 5A-5A.

FIG. 5B is a sectional view of the intraluminal medical deviceillustrated in FIG. 5, taken along line 5B-5B.

FIG. 6 is a sectional view of an alternative sleeve for inclusion in anintraluminal medical device.

FIG. 7 is a sectional view of a second alternative sleeve for inclusionin an intraluminal medical device.

FIG. 8 is a sectional view of a third alternative sleeve for inclusionin an intraluminal medical device.

FIG. 9 is a sectional view of a fourth alternative sleeve for inclusionin an intraluminal medical device.

FIG. 10 is a sectional view of a fifth alternative sleeve for inclusionin an intraluminal medical device.

FIG. 11 is a sectional view of a sixth alternative sleeve for inclusionin an intraluminal medical device.

FIG. 12 is a sectional view of a seventh alternative sleeve forinclusion in an intraluminal medical device.

FIG. 13 is a side view of an eighth alternative sleeve for inclusion inan intraluminal medical device.

FIG. 13A is a sectional view of the sleeve illustrated in FIG. 13, takenalong line 13A-13A.

FIG. 14 is a side view of a fourth exemplary intraluminal medicaldevice. The intraluminal medical device is shown in a firstconfiguration.

FIG. 15 is a side view of the fourth exemplary intraluminal medicaldevice between the first configuration and a second configuration.

FIG. 16 is a side view of the fourth exemplary intraluminal medicaldevice in the second configuration.

FIG. 17 is a side view of a fifth exemplary intraluminal medical devicein a second configuration.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describeand illustrate various exemplary medical devices. The description anddrawings are exemplary in nature and are provided to enable one skilledin the art to make and use one or more exemplary device. They are notintended to limit the scope of the claims in any manner.

The use of “e.g.,” “etc.,” “for instance,” “in example,” and “or” andgrammatically related terms indicates non-exclusive alternatives withoutlimitation, unless otherwise noted. The use of “optionally” andgrammatically related terms means that the subsequently describedelement, event, feature, or circumstance may or may not bepresent/occur, and that the description includes instances where saidelement, event, feature, or circumstance occurs and instances where itdoes not. As used herein, the terms “proximal” and “distal” are used todescribe opposing axial ends of the particular elements or featuresbeing described. The use of “bodily passage” or “body passage” refers toany passage within the body of an animal, including, but not limited to,humans, and includes elongate passages. The use of “exemplary” refers to“an example of” and is not intended to convey a meaning of an ideal orpreferred embodiment. The use of “circumferential” refers to thedistance around the particular element or feature being described and isnot intended to define any particular geometric shape.

FIGS. 1, 1A, 1B, 1C, and 2 illustrate a first exemplary intraluminalmedical device 10. The intraluminal medical device 10 comprises a frame12 and a sleeve 14 attached to the frame 12. The frame 12 and sleeve 14cooperatively define a device lumen 16 that extends through the lengthof the intraluminal medical device 10.

Frame 12 can comprise any suitable frame, and skilled artisans will beable to select a suitable frame according to a particular embodimentbased on various considerations, including the bodily passage withinwhich the device is intended to be used. Example frames consideredsuitable include, but are not limited to, expandable, self-expandable,and frames that require the application of a force to effect expansion,such as balloon expandable frames. The structural characteristics ofthese types of frames are known in the art, and are not detailed herein.

Frame 12 can be formed of any suitable material and have any suitableproportions. A skilled artisan will be able to select a suitablematerial and suitable proportions for a frame based on variousconsiderations, including the bodily passage within which the device isintended to be used. The material selected for a frame need only bebiocompatible or able to be made biocompatible. Example materialsconsidered suitable include, without limitation, stainless steel, nickeltitanium (NiTi) alloys, e.g., nitinol, other shape memory and/orsuperelastic materials, molybdenum alloys, tantalum alloys, titaniumalloys, palladium alloys, precious metals such as platinum, preciousmetal alloys such as platinum alloys, nickel chromium alloys, cobaltchromium alloys, nickel cobalt chromium alloys, nickel cobalt chromiummolybdenum alloys, nickel titanium chromium alloys, linear elasticNitinol wires, polymers, and composite materials. The inventors havedetermined that frames having a length between about 2 cm and about 18cm are considered suitable. In addition, the inventors have determinedthat frames having a diameter between about 1 mm to about 30 mm areconsidered suitable.

A number of resorbable materials also can be used to form a frame. Asused herein, the term “resorbable” refers to the ability of a materialto be absorbed into a tissue and/or body fluid upon contact with thetissue and/or body fluid. A number of resorbable materials are known inthe art, and any suitable resorbable material can be used. Examples ofsuitable types of resorbable materials include resorbable homopolymers,copolymers, or blends of resorbable polymers. Specific examples ofsuitable resorbable materials include poly-alpha hydroxy acids such aspolylactic acid, polylactide, polyglycolic acid (PGA), or polyglycolide;trimethylene carbonate; polycaprolactone; poly-beta hydroxy acids suchas polyhydroxybutyrate or polyhydroxyvalerate; or other polymers such aspolyphosphazines, polyorganophosphazines, polyanhydrides,polyesteramides, polyorthoesters, polyethylene oxide, polyester-ethers(e.g., polydioxanone) or polyamino acids (e.g., poly-L-glutamic acid orpoly-L-lysine). There are also a number of naturally derived resorbablepolymers that may be suitable, including modified polysaccharides, suchas cellulose, chitin, and dextran, and modified proteins, such as fibrinand casein. Absorbable metals and minerals, such as magnesium andcalcium, are also considered suitable.

Bioremodellable materials also can be used to form a frame. As usedherein, the term “bioremodellable” refers to the ability of a materialto remodel and become incorporated into adjacent tissues. Thesematerials can provide a scaffold onto which cellular in-growth canoccur, eventually allowing the material to remodel into a structure ofhost cells. A number of bioremodellable materials are known in the art,and any suitable bioremodellable material can be used. Examples ofsuitable bioremodellable materials include extracellular matrix (ECM)materials, such as small intestine submucosa (SIS), bovine pericardium,stomach submucosa, liver basement membrane, urinary bladder submucosa,tissue mucosa, and dura mater.

Platinum and nitinol are currently considered desirable materials foruse in the frame 12 due at least to their biocompatibility,shapeability, imaging characteristics, and well-characterized nature.Stainless steel is also considered a suitable material for use in theframe 12. Also, cold drawn cobalt chromium alloys, such as AS™ F562 andAS™ F1058 (commercial examples of which include MP35N™ and Elgiloy™,both of which are available from Fort Wayne Metals, Fort Wayne, Ind.;MP35N is a registered trademark of SPS Technologies, Inc. (Jenkintown,Pa., USA); Elgiloy is a registered trademark of Combined Metals ofChicago LLC (Elk Grove Village, Ill., USA)), are currently consideredadvantageous materials for use in the frame 12 at least because they arenon-magnetic materials that provide beneficial magnetic resonanceimaging (MRI) compatibility, and avoid MRI artifacts typicallyassociated with some other materials, such as stainless steel.

Frame 12 can optionally include a covering disposed around a portion, orthe entirety, of the circumferential length and/or axial length of theframe. Any suitable covering can be included in any of the intraluminalmedical devices describer herein, and skilled artisans will be able toselect a suitable covering for an intraluminal medical device accordingto a particular embodiment based on various considerations, includingthe desired bodily passage within which the intraluminal medical deviceis intended to be deployed. If included, a covering need only be able tobe attached or otherwise connected to the frame of an intraluminalmedical device.

A covering comprises a section of material, such as a sheet, that isattached to the frame of an intraluminal medical device. The coveringcan be formed of any suitable material, and skilled artisans will beable to select a suitable material to form a covering according to aparticular embodiment based on various considerations, including thedesired bodily passage within which the intraluminal medical device isintended to be deployed. Example materials considered suitable to form acovering include, but are not limited to, biocompatible materials,materials that can be made biocompatible, flexible materials, naturalmaterials, synthetic materials, combinations of natural materials andsynthetic materials, any suitable material described herein, and anyother material considered suitable for a particular application.Examples of suitable natural materials include, but are not limited to,extracellular matrix (ECM) materials, such as small intestine submucosa(SIS), and other bioremodellable materials, such as bovine pericardium.Other examples of ECM materials that can be used include stomachsubmucosa, liver basement membrane, urinary bladder submucosa, tissuemucosa, and dura matter. Examples of suitable synthetic materialsinclude polymeric materials, such as expanded polytetrafluoroethyleneand polyurethane. ECM materials are considered suitable to form coveringat least because of their abilities to remodel and become incorporatedinto adjacent tissues, facilitating anchoring of an intraluminal medicaldevice at a point of treatment in a body passage. These materials canprovide a scaffold onto which cellular in-growth can occur, eventuallyallowing the material to remodel into a structure of host cells. It isnoted that two or more different materials can be used to form thecovering.

The covering can be attached to the frame in any suitable manner andusing any suitable means for attaching a covering to a frame, such assutures, clips, and other mechanical attachment elements. Alternatively,bonding agents and/or techniques can be used, such as adhesives, heatsealing, tissue welding, and cross-linking. Furthermore, directattachment of the covering to the frame can be used. For example, thestruts of the frame can be woven through the covering to create anattachment. Also, the frame can be embedded within the covering, such asby dipping and spraying a polymeric material onto the frame to form anattached covering. The specific manner in which a particular covering isattached to an intraluminal medical device will depend at least upon thematerials used in the covering and the frame. Example methods ofattaching a covering to a frame include, but are not limited to,attaching a covering to an inner frame surface along a portion, or theentirety, of the circumferential length and/or axial length of theframe, attaching a covering to an outer frame surface along a portion,or the entirety, of the circumferential length and/or axial length ofthe frame, dipping and/or spraying a portion, or the entirety, of thecircumferential length and/or axial length of a frame with a coveringmaterial, attaching a covering to an inner frame surface along aportion, or the entirety, of the circumferential length and/or axiallength of the frame and dipping and/or spraying a portion, or theentirety, of the circumferential length and/or axial length of the framewith a covering material, and attaching a covering to an outer framesurface along a portion, or the entirety, of the circumferential lengthand/or axial length of the frame and dipping and/or spraying a portion,or the entirety, of the circumferential length and/or axial length ofthe frame with a covering material.

Frame 12 can have a variety of shapes and structural arrangements,including braided strands, helically wound strands, ring members,consecutively attached ring members, zig-zag members, tubular members,frames cut from solid tubes, and solid tubular members. A skilledartisan will be able to select a suitable shape and structuralarrangement for a frame according to a particular embodiment based onvarious considerations, such as the bodily passage within which thedevice is intended to be used. Frames for use in the intraluminalmedical devices described herein can be formed in a variety of manners.For example, a frame can be formed from one or more wires, such as fromlengths of wire having a circular, D-shaped or other suitablecross-sectional configuration. Also, a frame can be cut from a tubularmember, such as by cutting a desired pattern of struts from a tubularsection of a suitable material. No matter the type of frame used in anintraluminal medical device according to a particular embodiment, theframe can include any suitable arrangement of struts.

In the illustrated embodiment, frame 12 comprises a self-expandable wiremesh frame with a plurality of intersecting wire portions and aplurality of mesh openings. The frame 12 has a first frame end 18 and asecond frame end 20. The first frame end 18 defines a first frame endopening 22 and the second frame end 20 defines a second frame endopening 24. The frame 12 has inner frame surface 26 and an outer framesurface 28 and defines a frame lumen 30 that extends from the firstframe end 18 to the second frame end 20.

Sleeve 14 can comprise any suitable member having any suitablestructural arrangement, and skilled artisans will be able to select asuitable member and structural arrangement according to a particularembodiment based on various considerations, including the bodily passagewithin which the device is intended to be used. Example structuralarrangements considered suitable for a sleeve include, but are notlimited to, tubular, a sleeve with a proximal portion having a firstconfiguration and a distal portion with a second, different,configuration, and a sleeve having multiple structural configurationsalong its axial length and/or circumferential length. For example, asleeve can have a first portion that extends from the proximal end ofthe sleeve towards the distal end that has a first tubular and/orcylindrical configuration and a second portion that extends from thedistal end towards the proximal end that has a second, different,configuration. The second portion can comprise any suitableconfiguration. Example configurations considered suitable for the secondportion of a sleeve include, but are not limited to, cylindrical,beak-shaped, tricuspid-shaped, cone-shaped, tapered, rectangular,square, semi-circular, chisel-shaped, hemi-spherical, curved (e.g.,axial view is configured like a smile), and spherical. Sleeve 14 needonly be adapted to be invertible into the frame lumen 30, partiallyinvertible into the frame lumen 30, or non-invertible, as describedherein.

Sleeve 14 can be formed of any suitable material, and skilled artisanswill be able to select a suitable material for a sleeve according to aparticular embodiment based on various considerations, including thebodily passage within which the device is intended to be used. Thematerial selected for a sleeve need only be biocompatible or able to bemade biocompatible. Examples of suitable materials include, polymers,shape memory polymers, polytetrafluoroethylene (PTFE), elastomeric PTFE,polyurethane, shape memory polyurethane, polyethylene, UHMWpolyethylene, elastomeric polyethylene, low density (LD) polyethylene,high density (HD) polyethylene, polypropylene, polyethyleneterephthalate (PET), polyethyleneoxide (PEO), block copolymerscontaining polystyrene and poly(1,4-butadiene), an ABA triblockcopolymer made from poly(2-methyl-2-oxazoline) and polytetrahydrofuran,amorphous or organic-inorganic hybrid polymers consisting ofpolynorbornene units, and poly-silicone.

In the illustrated embodiment, sleeve 14 is a tubular member having afirst sleeve end 32, a second sleeve end 34, an axial length 35 thatextends from the first sleeve end 32 to the second sleeve end 34, and acircumferential length 41, as illustrated in FIG. 1C. The first sleeveend 32 is attached to the second frame end 20 by dipping the secondframe end 20 into the material forming sleeve 12. The first sleeve end32 defines a first end opening 36 and the second sleeve end 34 defines asecond end opening 38. The sleeve 14 has an inner sleeve surface 40 andan outer sleeve surface 42 and defines a sleeve lumen 44 that extendsfrom the first sleeve end 32 to the second sleeve end 34.

The second sleeve end 34 is adapted to have a first configuration, asillustrated in FIG. 1, and a second configuration, as illustrated inFIG. 2. In the first configuration, the second end opening 38 is sealed,or substantially sealed, along a portion, or the entirety, of thecircumferential length 41 such that materials (e.g., food) and/or fluids(e.g., water) are prevented from passing through the second end opening38. In the second configuration, the second end opening 38 is open suchthat materials and/or fluid can pass through the second end opening 38.Second sleeve end 34 is adapted to be in the first configuration inwhich the second end opening 38 is sealed, or substantially sealed,under normal pressures in the bodily passage within which theintraluminal medical device is disposed.

The inventors have determined that the seal created on the sleeve secondend is directly correlated with the thickness of the sleeve. Forexample, a sleeve having a first wall thickness on the second sleeve endwill create a greater seal as compared to a sleeve having a second wallthickness on the sleeve second end that is greater than the first wallthickness. Thus, a greater seal can be accomplished by using a thinnerwall thickness at the sleeve send end, or any portion thereof. Theinventors have also determined that the shape of the sleeve second endalso affects the extent at which a seal is created.

Sleeve 14 can have any suitable axial length and circumferential length,and skilled artisans will be able to select a suitable axial length andcircumferential length for a sleeve according to a particular embodimentbased on various considerations, including the desired amount offlexibility of the sleeve. The inventors have determined that a sleevehaving an axial length between about 1 mm to about 70 mm is consideredsuitable. The inventors have also determined that a sleeve having anaxial length between about 20 mm to about 45 mm is considered suitable.

Sleeve 14 has a first portion 46 and a second portion 48. The firstportion 46 of the sleeve 14 extends from the second sleeve end 34towards the first sleeve end 32 along a first portion 37 of the axiallength 35 of the sleeve 14 and along a first portion 43 of thecircumferential length 41 of the sleeve 14, as illustrated in FIG. 1C.The second portion 48 of the sleeve 14 extends from the first sleeve end32 towards the second sleeve end 34 along a second portion 39 of theaxial length 35 of the sleeve 14 and along the circumferential length 41of the sleeve 14. Along the first portion 37 of the axial length 35 ofthe sleeve, the second portion 48 extends along a second portion 45 ofthe circumferential length 41 of the sleeve 14, as illustrated in FIG.1C.

As best illustrated in FIG. 1A, the first portion 46 has a first wallthickness 50 that extends from the outer sleeve surface 42 to the innersleeve surface 40. As best illustrated in FIG. 1B, the second portion 48has a second wall thickness 52 that extends from the inner sleevesurface 40 to the outer sleeve surface 42. Thus, the second wallthickness 52 of the sleeve 14 is disposed at the point of attachment toframe 12. The first wall thickness 50 is different from the second wallthickness 52. In the illustrated embodiment, the first wall thickness 50is greater than the second wall thickness 52.

The differential wall thicknesses 50, 52 can vary along the axial length35 and/or the circumferential length of sleeve 14, and skilled artisanswill be able to select suitable differential wall thicknesses for asleeve according to a particular embodiment based on variousconsiderations, including the desired flexibility of the sleeve. Theinventors have determined that wall thicknesses between about 0.00254 mmand about 1.016 mm are considered suitable.

While differential wall thicknesses 50, 52 have been described, a sleevecan have any suitable wall thickness along the entirety, or a portion,of the axial length and/or circumferential length of the sleeve, andskilled artisans will be able to select a suitable wall thickness forthe entirety, or a portion, of the axial length and/or circumferentiallength of a sleeve according to a particular embodiment based on variousconsiderations, including the desired flexibility of the sleeve. Examplestructural arrangement considered suitable include, but are not limitedto, a continuous wall thickness along the entire length of the sleeve, avarying wall thickness along the length of the sleeve (e.g., a firstportion of the axial length and/or circumferential length having a firstwall thickness and a second portion of the axial length and/orcircumferential length having a second, different, wall thickness), agradual increase in the wall thickness from the first sleeve end to thesecond sleeve end, a gradual decrease in the wall thickness from thefirst sleeve end to the second sleeve end, and a sleeve having a firstportion disposed between the first sleeve end and the second sleeve endthat has a greater wall thickness than the wall thickness at the firstsleeve end and the second sleeve end.

Sleeve 14 can be formed using any suitable technique to achieve desireddifferential wall thicknesses 50, 52, and skilled artisans will be ableto select a suitable technique to form a sleeve according to aparticular embodiment based on various considerations, including thedesired flexibility of the sleeve. Example techniques consideredsuitable to form a sleeve include, but are not limited to, dipping orspraying a mandrel formed of PTFE with one or more coats of a polymer toachieve desired differential wall thicknesses either before or afterattachment of a sleeve to a frame. For example, a sleeve can be formedby applying one or more polymer coats (e.g., dipping, spraying) to thesurface of a mandrel formed of PTFE. By isolating areas of the mandrelduring the coating process, a sleeve can be coated to tailor fit thedesign requirements of a particular sleeve (e.g., a first portion havinga thickness greater than a second portion). The greater number ofpolymer coats applied to the mandrel, the thicker the wall of a sleeve.Further examples of techniques considered suitable to achieve desireddifferential wall thicknesses included, but are not limited to, forminga sleeve, or portions thereof, of a laminate or of a unitary structure.Other methods considered suitable to form a sleeve include, but are notlimited to, blow molding, casting, extruding, electrospinning, heatforming, spraying, weaving, knitting, and braiding.

In the illustrated embodiment, sleeve 14 is adapted to move between anextended position in which the second end 34 and a part of the secondportion 48 are disposed outside of the frame lumen 30 to an invertedposition in which the second end 34 and the part of the second portion48 are disposed within the frame lumen 30. The intraluminal medicaldevice 10 is in a first configuration, illustrated in FIG. 1, when thesleeve 14 is in the extended position and in a second configuration,illustrated in FIG. 2, when the sleeve 14 is in the inverted position.

It is considered advantageous to attach the second portion 48 of thesleeve 14, which has a second wall thickness 52 that is less than thefirst wall thickness 50, to the frame 12 to control the amount ofpressure required to move the sleeve 14 from an extended position to aninverted position, and vice versa. For example, the first sleeve end 32having a second wall thickness 52 that is less than the first wallthickness 50 allows for the sleeve 14 to move from the extended positionto the inverted position, and vice versa, with the application of asmaller amount of pressure as compared to a first sleeve end 32 having afirst wall thickness 50.

While the first sleeve end 32 has been described and illustrated asattached to the second frame end 20, sleeve 14 can be attached to theframe 12 at any suitable location along the axial length of the frame12. A skilled artisan will be able to select a particular location toattach a sleeve to a frame according to a particular embodiment based onvarious considerations, such as the bodily passage within which thedevice is intended to be used. Example locations considered suitable toattach a sleeve to a frame include, but are not limited to, attaching aportion, or the entirety, of a first sleeve end to a first frame end,attaching a portion, or the entirety, of a first sleeve end to a secondframe end, and attaching a portion, or the entirety, of a first sleeveend at a location between a first frame end and a second frame end.Further example locations considered suitable to attach a sleeve to aframe include, but are not limited to, attaching a portion, or theentirety, of a sleeve to a first frame end, attaching a portion, or theentirety, of a sleeve to a second frame end, and attaching a portion, orthe entirety, of a sleeve at a location between a first frame end and asecond frame end.

The differential wall thicknesses 50, 52 can be positioned on the sleeve14 in any suitable arrangement, and skilled artisans will be able toselect a suitable arrangement for a particular embodiment based onvarious considerations, including the desired pressure at which a sleeveis to invert. Example arrangements considered suitable for positioning afirst portion and a second portion on a sleeve include, but are notlimited to, having a first portion that extends along a portion, or theentirety, of the axial length of a sleeve, a first portion that extendsalong a portion, or the entirety, of the circumferential length of asleeve, a second portion that extends along a portion, or the entirety,of the axial length of a sleeve, a second portion that extends along aportion, or the entirety, of the circumferential length of a sleeve, afirst portion that extends along a portion of the circumferential lengthof a sleeve and a second portion that extends along another portion ofthe circumferential length of the sleeve, and/or a first portion thatextends along a portion of the axial length of a sleeve and a secondportion that extends along another portion of the axial length of thesleeve. In addition, it is also considered suitable to include varyingwall thicknesses (e.g., first wall thickness 50, second wall thickness52) at one or more locations along the axial length and/orcircumferential length of a sleeve. For example, on any planar sectionorthogonal to the lengthwise axis of the sleeve 14, the wall thicknesscan vary around the circumferential length 41 of the sleeve 14.

A sleeve, or a portion thereof (e.g., first sleeve end), can be attachedto the frame using any suitable structure and/or method of attachment,and skilled artisans will be able to select a suitable structure andmethod for attaching a sleeve to a frame according to a particularembodiment based on various considerations, including the bodily passagewithin which the device is intended to be used. Example methods ofattachment between the frame and sleeve considered suitable include, butare not limited to, any method capable of bonding and/or attaching asleeve to a frame, or any portion thereof (e.g., covering of the frame),using sutures, adhesives (e.g., silicone adhesives), ultraviolet curing,bonding, dipping, spraying, heat welding, and mechanical methods ofattachment (e.g., clips, rings). Alternatively, the sleeve can becreated in conjunction with the membrane of the stent.

Optionally, the entirety, or portions of, the frame 12 and/or sleeve 14can comprise certain materials that permit identification of theposition and/or orientation of the intraluminal medical device 10, frame12, and/or sleeve 14 within a body passage. The frame 12 and/or sleeve14 can include one or more radiopaque markers, and/or be formed of aradiopaque material, to aid a user in positioning the intraluminalmedical device 10, frame 12, and/or sleeve 14 in a body passage. Forexample, the sleeve 14 can be formed of a material that can beidentified by X-ray by adding radiopaque ingredients to a base polymer,which is dipped and/or sprayed onto the sleeve 14 during manufacture. Itis considered advantageous to include a radiopaque material in aportion, or the entirety, of sleeve 14 to allow a user to observe thesleeve 14 moving from an extended position to an inverted position, andvice versa.

The radiopaque material may be added in any fabrication method orabsorbed into or sprayed onto the surface of the entirety, or a portion,of the frame 12 and/or sleeve 14. The degree of radiopacity contrast canbe altered by the type and amount of material incorporated into theframe 12 and/or sleeve 14. Common radiopaque materials include bariumsulfate, bismuth subcarbonate, and zirconium dioxide. Other radiopaqueelements include cadmium, tungsten, gold, tantalum, bismuth, platinum,iridium, and rhodium. Radiopacity is typically determined by fluoroscopeor x-ray film.

In use, the intraluminal medical device 10 can be pre-loaded into adelivery device with the sleeve 14 in the extended position or theinverted position. It is considered advantageous to load theintraluminal medical device 10 into a delivery device with the sleeve 14in the inverted position at least because this configuration wouldreduce the clinical complications with introducing the intraluminalmedical device 10 into a bodily passage. Subsequent to delivery, thesleeve 14 can be moved to the extended position by passing a material(e.g., food) and/or fluid (e.g., water) through the lumen 30 of theframe 12 and through the lumen 44 of the sleeve 14. In instances wherethe intraluminal medical device 10 includes radiopaque material,successful inversion of the sleeve from the inverted position to theextended position can be confirmed under X-ray.

Optionally, the sleeve 14 can be disposed within a dissolvable sleeveformed of biocompatible material to reduce the likelihood ofself-adherence. The dissolvable sleeve need only be biocompatible andable to dissolve in the contents of the bodily passage (e.g., stomach).Skilled artisans will be able to select a suitable material to form thedissolvable sleeve according to a particular embodiment based on variousconsiderations, including the bodily passage within which the device isintended to be used. Example materials considered suitable to form adissolvable sleeve include, but are not limited to, any suitablematerial described herein, absorbable materials, absorbable minerals,magnesium, and calcium.

The intraluminal medical devices described herein can be placed (e.g.,implanted) in any suitable bodily passage, including arteries, veins,ducts, canals, any bodily passage of the pulmonary system, any bodilypassage of the vasculature, any bodily passage of the urological system,any bodily passage of the gastric system, any bodily passage of thecardiovascular system, and any other suitable passage where the controlof fluid flow and/or materials through the bodily passage is desired.The intraluminal medical devices described herein are consideredparticularly advantageous for placement in the esophagus to reduce theoccurrence of stomach contents from entering the esophagus. In addition,the intraluminal medical devices described herein are consideredadvantageous for placement in the vasculature, bile duct, and portionsof the urinary system, such as the ureter, to regulate the fluid flowand/or materials through the bodily passages.

For example, it is considered advantageous to place an intraluminalmedical device, such as one described herein, along a portion of thelength of the esophagus such that the frame is deployed across theesophageal sphincter and the distal end of the intraluminal medicaldevice (e.g., second sleeve end) is disposed within the stomach when theintraluminal medical device is in the extended position. Thisadvantageously allows for materials to pass into the stomach when thesecond sleeve end is in the first configuration and reduces thelikelihood of the stomach contents from entering the esophagus when thesecond sleeve end is in a second, sealed, configuration. When sufficientpressure is placed on a portion, or the entirety, of the sleeve (e.g.,during vomiting), the sleeve moves to the inverted position, allowingfor the contents of the stomach, or a portion thereof, to move throughthe sleeve and the esophagus. Subsequently, the sleeve can be moved fromthe inverted position to the extended position by passing a material(e.g., water) through the esophagus and the intraluminal medical devicetowards the stomach. A structural feature can be included in anintraluminal medical device that facilitates self reversion of thesleeve, such as a spring or a material with desirable properties.

While the intraluminal medical device has been described as positionedin a particular location, the intraluminal medical device can bepositioned at any suitable point along the length of the esophagus, andskilled artisans will be able to select a suitable position along thelength of the esophagus based on various considerations, including thedesired location of the distal end of an intraluminal medical device.Example locations considered suitable to position an intraluminalmedical device include, but are not limited to, positioning anintraluminal medical device such that the distal end of the intraluminalmedical device (e.g., second sleeve end) is disposed within theesophagus, positioning an intraluminal medical device such that thedistal end of the intraluminal medical device (e.g., second sleeve end)is disposed within the esophageal sphincter, and positioning anintraluminal medical device such that the distal end of the intraluminalmedical device (e.g., second sleeve end) is disposed within the stomach.

The inventors have determined that the wall thickness of a sleeve has adirect correlation with the pressure required to invert a sleeve (e.g.,inversion pressure), when inversion is a desired characteristic of asleeve (e.g., in cylindrical sleeves this is correlated with hoopstress). For example, under certain pressures the second sleeve secondend will seal, or substantially seal, in order to create a pressuregradient where the pressure distal to the second sleeve end is greaterthan the pressure proximal to the second sleeve end. Once a pressuregradient is created the sleeve can invert. The inventors have determinedthat a reduction in the inversion area—the amount of a sleeve adapted toinvert into the lumen of a frame—results in an increase in the pressurerequired to invert the sleeve. In addition, the inventors havedetermined that an increase in the wall thickness and/or axial length ofa sleeve results in an increase in the pressure required to invert asleeve.

Alternatively, when a sleeve is adapted to only partially invert, thesleeve first end, the sleeve second end, or a combination of the sleevefirst end and the sleeve second end, can be adapted to prevent theentire axial length of the sleeve, or a portion thereof, from invertinginto the frame. This can be accomplished, for example, by configuringthe sleeve to have a sleeve second end that has a first wall thicknessthat is greater than a second wall thickness at the sleeve first end.Alternatively, this configuration can be accomplished by incorporating asecond material (e.g., shape memory material, nitinol) into the sleevefirst end, sleeve second end, and/or a portion of the sleeve between thesleeve first end and the sleeve second end that is different than afirst material forming the sleeve. This configuration is consideredadvantageous at least because it reduces the amount of pressure releasedwhen the sleeve is in the inverted position and prior to the sleevesecond opening moving from the second configuration to the firstconfiguration.

The inventors have also determined that there is a direct correlationbetween the wall thickness of the sleeve, or a portion thereof, and thevolume of fluid and/or material required to revert the sleeve to theextended position from the inverted position (e.g., reversion volume).For example, a sleeve having a first wall thickness that less than asleeve having a second, greater, wall thickness requires a smalleramount of material and/or fluid to move the sleeve from the invertedposition to the extended position. Alternative to requiring a materialand/or fluid to revert the sleeve, including a sleeve having a greaterwall thickness on a portion of the circumferential length and/or axiallength of the sleeve can enable the sleeve to self-revert. This can beaccomplished, for example, by including a greater wall thickness (e.g.,ridge, wedge, strip, or any region that incorporates an area having athickness greater than a thickness of an area in another region) on aportion of the axial length and/or circumferential length of a sleeve(e.g., the sleeve second end).

Optionally, sleeve 14 can be formed such that it is biased to theextended position. Biasing a sleeve can be accomplished using anysuitable method and or structure, and skilled artisans will be able toselect a suitable method and/or structure to bias a sleeve according toa particular embodiment based on various considerations, including thelength of the sleeve, the thickness of the sleeve, the inversion area ofthe sleeve, the shape of the sleeve, and/or the material forming thesleeve. An example method of biasing a sleeve includes, but is notlimited to, including a sleeve with a first thickness at the sleevesecond end that is less than the thickness of the sleeve at the sleevefirst end and a portion of the sleeve between the sleeve first end andthe sleeve second end. Example methods considered suitable to form asleeve having a bias to the extended position or the inverted positioninclude, but are not limited to, dipping, electrospinning, extruding,blow molding, heat forming, spraying, weaving, knitting, and braiding.

Alternatively, or in combination with having a sleeve with a firstthickness at the sleeve second end that is less than the thickness ofthe sleeve at the sleeve first end and a portion of the sleeve betweenthe sleeve first end and the sleeve second end, the sleeve can includeone or more reinforcing elements formed of a shape memory material(e.g., nitinol) attached to the exterior surface, interior surface,and/or embedded within the wall of the sleeve, along the entire axiallength, a portion of the axial length of the sleeve, the entirecircumferential length of the sleeve, or a portion of thecircumferential length of the sleeve, such that the sleeve is biased tothe extended position or inverted position.

FIGS. 3, 3A, 3B, and 4 illustrate a second exemplary intraluminalmedical device 110. The intraluminal medical device 110 is similar tothe intraluminal medical device 10 illustrated in FIGS. 1, 1A, 1B, 1C,and 2 and described above, except as detailed below. Reference numbersin FIGS. 3, 3A, 3B, and 4 refer to the same structural element orfeature referenced by the same number in FIGS. 1, 1A, 1B, 1C, and 2,offset by 100. Thus, the intraluminal medical device 110 comprises aframe 112 and a sleeve 114 attached to the frame 112. The frame 112 andsleeve 114 cooperatively define a device lumen 116 that extends throughthe length of the intraluminal medical device 110.

In the illustrated embodiment, the first sleeve end 132 is attached tothe second frame end 120 using sutures 160. The first portion 146 of thesleeve 114 extends from the first sleeve end 132 towards the secondsleeve end 134 along a first portion 137 of the axial length 135 of thesleeve 114 and along a first portion 143 of the circumferential length141 of the sleeve 114, as illustrated in FIG. 3A. The second portion 148of the sleeve 114 extends from the second sleeve end 134 towards thefirst sleeve end 132 along a second portion 139 of the axial length 135of the sleeve and along the circumferential length 141 of the sleeve114, as illustrated in FIG. 3B. Along the first portion 137 of the axiallength 135 of the sleeve 114, the second portion 148 extends along asecond portion 145 of the circumferential length 141 of the sleeve 114,as illustrated in FIG. 3A. Thus, the first wall thickness 150 and thesecond wall thickness 152 of the sleeve 114 are disposed at the point ofattachment to frame 112.

It is considered advantageous to attach the first portion 146 of thesleeve 114, which has a first wall thickness 150 greater than the secondwall thickness 152, to the frame 112 to control the amount of pressurerequired to move the sleeve 114 from an extended position to an invertedposition, and vice versa. For example, the first sleeve end 132 having afirst portion 143 of the circumferential length 141 having a first wallthickness 150 allows for the sleeve 114 to move from the extendedposition to the inverted position, and vice versa, with the applicationof a greater amount of pressure as compared to a first sleeve end 132having a circumferential length 141 with a second wall thickness 152.

While the first portion 146 has been described and illustrated asextending along a first portion 137 of the axial length 135 and along afirst portion 143 of the circumferential length 141 of sleeve 114, anysuitable axial length and/or circumferential length, including theentire axial length and/or circumferential length, can be used. Askilled artisan will be able to select a suitable axial length and/orcircumferential length for a first portion according to a particularembodiment based on various considerations, including the desiredpressure at which a sleeve moves from an extended position to aninverted position.

In addition, while the second portion 148 has been described andillustrated as extending along the axial length 135 and along a secondportion 145 of the circumferential length 141 of sleeve 114 along thefirst portion 137 of the axial length 135, any suitable axial lengthand/or circumferential length, including the entire axial length and/orcircumferential length, can be used. A skilled artisan will be able toselect a suitable axial length and/or circumferential length for asecond portion according to a particular embodiment based on variousconsiderations, including the desired pressure at which a sleeve movesfrom an extended position to an inverted position.

Any suitable combination of axial lengths and/or circumferential lengthscan be used for a first portion and/or a second portion, and skilledartisans will be able to select a suitable combination of axial lengthsand/or circumferential lengths for a first portion and/or a secondportion according to a particular embodiment based on variousconsiderations, including the desired pressure at which a sleeve movesfrom an extended position to an inverted position.

Second sleeve end 134 is adapted to have a first configuration, asillustrated in FIG. 3, and a second configuration, as illustrated inFIG. 4. In the first configuration, the second end opening 138 issealed, or substantially sealed, along a portion, or the entirety, ofthe circumferential length 141 such that materials (e.g., food) and/orfluid (e.g., water) are prevented from passing through the second endopening 138. In the second configuration, the second end opening 138 isopen such that materials and/or fluid can pass through the second endopening 138.

Sleeve 114 is adapted to be invertible from an extended position inwhich the second end 134 and a part of the first portion 146 aredisposed outside of the frame lumen 130 to an inverted position in whichthe second end 134 and the part of the first portion 146 are disposedwithin the frame lumen 130. The intraluminal medical device 110 is in afirst configuration, illustrated in FIG. 3, when the sleeve 114 is inthe extended position and in a second configuration, illustrated in FIG.4, when the sleeve 114 is in the inverted position.

FIGS. 5, 5A and 5B illustrate a third exemplary intraluminal medicaldevice 210. The intraluminal medical device 210 is similar to theintraluminal medical device 10 illustrated in FIGS. 1, 1A, 1B, 1C, and 2and described above, except as detailed below. Reference numbers inFIGS. 5, 5A, and 5B refer to the same structural element or featurereferenced by the same number in FIGS. 1, 1A, 1B, 1C, and 2, offset by200. Thus, the intraluminal medical device 210 comprises a frame 212 anda sleeve 214 attached to the frame 212. The frame 212 and sleeve 214cooperatively define a device lumen 216 that extends through the lengthof the intraluminal medical device 210. Sleeve 214 is illustrated in thesecond configuration such that second end opening 238 is open to allowmaterial and/or fluids to pass through send end opening 238.

In the illustrated embodiment, first sleeve end 232 is attached to thesecond frame end 220. The first portion 246 is disposed on the firstsleeve end 232 and extends towards the second sleeve end 234 and thesecond portion 248 is disposed on the second sleeve end 234 and extendstowards the first sleeve end 232. Sleeve 214 defines a continuous, orsubstantially continuous, taper on the inner sleeve surface 240 andouter sleeve surface 242 along the axial length 235 of sleeve 214. Thewall thickness of the sleeve tapers from the first wall thickness 250 atthe first sleeve end 232 to the second wall thickness 252 at the secondsleeve end 234 and extends from the first sleeve end 232 to the secondsleeve end 234. Thus, the first wall thickness 250 tapers to the secondwall thickness 252 from the first sleeve end 246 to the second sleeveend 248. As best illustrated in FIGS. 5A and 5B, on any planar sectionorthogonal to the lengthwise axis of the sleeve 214, the wall thicknessis constant, or substantially constant, around the entirecircumferential length 241 of the sleeve 214. Alternatively, asindicated above, the wall thickness can vary at one or more locationsalong the circumferential length and/or axial length of a sleeve.Skilled artisans will be able to select a suitable wall thickness for asleeve according to a particular embodiment based on variousconsiderations, including the bodily passage within which the device isto be used.

Sleeve 214 is adapted to be invertible from an extended position inwhich the second end 234 and a part of the first portion 246 aredisposed outside of the frame lumen 230 to an inverted position in whichthe second end 234 and the part of the first portion 246 are disposedwithin the frame lumen 230.

While the sleeve 214 is described and illustrated as defining a taper onthe inner sleeve surface 240 and outer sleeve surface 242, various othermethods of tapering a sleeve are considered suitable, and skilledartisans will be able to select a suitable method according to aparticular embodiment based on various considerations, including thedesired pressure at which the sleeve will move from an expanded positionto an inverted position. Example methods considered suitable include,but are not limited to, defining a taper on an outer sleeve surface andhaving an inner sleeve surface that is parallel, or substantiallyparallel, to the lengthwise axis of a sleeve, and defining a taper on aninner sleeve surface and having an outer sleeve surface that isparallel, or substantially parallel, to the lengthwise axis of a sleeve.The sleeve in a particular embodiment, though, can have any suitablesize, shape and configuration.

It is considered advantageous to include the second portion 248 having asecond wall thickness 252 that is less than the first wall thickness 250on the second sleeve end 234 to provide an increased dynamic response tothe sleeve 214 (e.g., during eating) when a pressure is exerted on thesecond sleeve end 234 and to allow the second sleeve end 234 to sealalong its circumferential length. It is also considered advantageous toposition the second wall thickness 252 on the second sleeve end 234 toallow the sleeve 214 to move from an expanded position to an invertedposition, and vice versa, with a lower amount of applied pressure on thesecond sleeve end 234. For example, when sufficient pressure is placedon the second sleeve end 234, or other portions of sleeve 214, thesleeve 214 will invert and move from the expanded position to theinverted position.

FIGS. 6, 7, 8, 9, 10, 11, and 12, each illustrate sectional views ofalternative sleeves for inclusion in an intraluminal medical device,such as intraluminal medical device 10.

FIG. 6 illustrates a sleeve 314 similar to sleeve 214 illustrated inFIGS. 5, 5A, and 5B, and described above, except as detailed below.Reference numbers in FIG. 6 refer to the same structural element orfeature referenced by the same number in FIGS. 5, 5A, and 5B, offset by100. Thus, sleeve 314 has a first sleeve end 332, a second sleeve end334, and an axial length 335 that extends from the first sleeve end 332to the second sleeve end 334. The first sleeve end 332 defines a firstend opening 336 and the second sleeve end 334 defines a second endopening 338. The sleeve 314 has an inner sleeve surface 340 and an outersleeve surface 342 and defines a sleeve lumen 344 that extends from thefirst sleeve end 332 to the second sleeve end 334. Sleeve 314 isillustrated in the second configuration such that second end opening 338is open to allow material and/or fluids to pass through send end opening438.

In the illustrated embodiment, sleeve 314 has a first portion 346 havinga first wall thickness 350, a second portion 347 having a second wallthickness 351, and a third portion 348 having a third wall thickness352. The second portion 347 is disposed between the first portion 346and the third portion 348. Each of the first wall thickness 350, secondwall thickness 351, and third wall thickness 352 extends from the innersleeve surface 340 to the outer sleeve surface 342.

The first portion 346 extends from the first sleeve end 332 towards thesecond sleeve end 334 to the proximal end of the second portion 347along a first portion 354 of the axial length 335 of sleeve 314. Thefirst portion 346 defines a taper on the inner sleeve surface 340 andthe outer sleeve surface 342 that extends along the first portion 354 ofthe axial length 335 of sleeve 314. The taper transitions the first wallthickness 350 disposed at the first sleeve end 332 to the second wallthickness 351 at the proximal end of the second portion 347. Thus, thefirst portion 346 has a wall thickness that tapers from the first sleeveend 332 to the proximal end of the second portion 347. While theillustrated embodiment includes a taper that transitions from the firstwall thickness 350 to the second wall thickness 351, any suitablestructural transition between two wall thicknesses can be included in asleeve of an intraluminal medical device according to a particularembodiment. Indeed, the sleeve can include a thickness that can increaseor decrease in any direction. Thus, the sleeve thickness can increase ordecrease in a proximal direction, a distal direction, along alongitudinal path on the sleeve, along a circumferential path along thesleeve, or along any suitable path on the sleeve.

The second portion 347 extends from the distal end of the first portion346 towards the second sleeve end 334 to the proximal end of the thirdportion 348. The second portion 347 defines a continuous, orsubstantially continuous, second wall thickness 351 that extends along asecond portion 355 of the axial length 335 of sleeve 314.

The third portion 348 extends from the distal end of the second portion347 to the second sleeve end 334. The third portion 348 defines acontinuous, or substantially continuous, third wall thickness 352 thatextends along a third portion 356 of the axial length 335 of sleeve 314.

The second wall thickness 351 and the third wall thickness 352 aredifferent from one another. In the illustrated embodiment, the secondwall thickness 351 is greater than the third wall thickness 352. Thus,the sleeve 314 defines a shoulder 370 at the location where the secondportion 347 and the third portion 348 meet. While the second wallthickness 351 has been illustrated and described as greater than thethird wall thickness 352, other wall thicknesses are consideredsuitable, and skilled artisans will be able to select a suitable wallthickness for a particular embodiment based on various considerations,such as the bodily passage within which the device will be used. Anexample thickness considered suitable includes, but is not limited to, asecond wall thickness that is less than a third wall thickness.

In the illustrated embodiment, on any planar section orthogonal to thelengthwise axis of the sleeve 314, the wall thickness of sleeve 314 isconstant, or substantially constant, around the entire circumferentiallength of the sleeve 314. Alternatively, as indicated above, the wallthickness can vary at one or more locations along the circumferentiallength and/or axial length of a sleeve. Skilled artisans will be able toselect a suitable wall thickness for a sleeve according to a particularembodiment based on various considerations, including the bodily passagewithin which the device is to be used.

FIG. 7 illustrates a sleeve 414 similar to sleeve 214 illustrated inFIGS. 5, 5A, and 5B, and described above, except as detailed below.Reference numbers in FIG. 7 refer to the same structural element orfeature referenced by the same number in FIGS. 5, 5A, and 5B, offset by200. Thus, sleeve 414 has a first sleeve end 432, a second sleeve end434, and an axial length 435 that extends from the first sleeve end 432to the second sleeve end 434. The first sleeve end 432 defines a firstend opening 436 and the second sleeve end 434 defines a second endopening 438. The sleeve 414 has an inner sleeve surface 440 and an outersleeve surface 442 and defines a sleeve lumen 444 that extends from thefirst sleeve end 432 to the second sleeve end 434. Sleeve 414 isillustrated in the second configuration such that second end opening 438is open to allow material and/or fluids to pass through send end opening438.

In the illustrated embodiment, sleeve 414 has a first portion 446 havinga first wall thickness 450 and a second portion 448 having a second wallthickness 452. Each of the first wall thickness 450 and second wallthickness 452 extends from the inner sleeve surface 440 to the outersleeve surface 442.

The first portion 446 extends from the first sleeve end 432 towards thesecond sleeve end 434 to the proximal end of the second portion 448along a first portion 454 of the axial length 435 of sleeve 414. Thefirst portion 446 defines a taper on the inner sleeve surface 440 andouter sleeve surface 442 that extends along the first portion 454 of theaxial length 435 of sleeve 414. The taper transitions the first wallthickness 450 disposed at the first sleeve end 432 to the second wallthickness 452 at the proximal end of the second portion 448. Thus, thefirst portion 446 has a wall thickness that tapers from the first sleeveend 432 to the proximal end of the second portion 447. In an alternativeembodiment, a sleeve of an intraluminal medical device has an oppositestructural arrangement.

The second portion 447 extends from the distal end of the first portion446 to the second sleeve end 434. The second portion 447 defines acontinuous, or substantially continuous, second wall thickness 452 thatextends along a second portion 455 of the axial length 435 of sleeve414.

In the illustrated embodiment, on any planar section orthogonal to thelengthwise axis of the sleeve 414, the wall thickness of sleeve 414 isconstant, or substantially constant, around the entire circumferentiallength of the sleeve 414. Alternatively, as indicated above, the wallthickness can vary at one or more locations along the circumferentiallength and/or axial length of a sleeve. Skilled artisans will be able toselect a suitable wall thickness for a sleeve according to a particularembodiment based on various considerations, including the bodily passagewithin which the device is to be used.

FIG. 8 illustrates a sleeve 514 similar to sleeve 214 illustrated inFIGS. 5, 5A, and 5B, and described above, except as detailed below.Reference numbers in FIG. 8 refer to the same structural element orfeature referenced by the same number in FIGS. 5, 5A, and 5B, offset by300. Thus, sleeve 514 has a first sleeve end 532, a second sleeve end534, and an axial length 535 that extends from the first sleeve end 532to the second sleeve end 534. The first sleeve end 532 defines a firstend opening 536 and the second sleeve end 534 defines a second endopening 538. The sleeve 514 has an inner sleeve surface 540 and an outersleeve surface 542 and defines a sleeve lumen 544 that extends from thefirst sleeve end 532 to the second sleeve end 534. Sleeve 414 isillustrated in the second configuration such that second end opening 438is open to allow material and/or fluids to pass through send end opening438.

In the illustrated embodiment, sleeve 514 has a first portion 546 havinga first wall thickness 550, a second portion 547 having a second wallthickness 551, a third portion 548 having a third wall thickness 552,and a fourth portion 549 having a fourth wall thickness 553. Each of thefirst wall thickness 550, second wall thickness 551, third wallthickness 552, and fourth wall thickness 553 extends from the innersleeve surface 540 to the outer sleeve surface 542.

The first portion 546 extends from the first sleeve end 532 towards thesecond sleeve end 534 to the proximal end of the second portion 547along a first portion 554 of the axial length 535 of sleeve 514. Thefirst portion 546 defines a taper on the inner sleeve surface 540 andthe outer sleeve surface 542 that extends along the first portion 554 ofthe axial length 535 of sleeve 514. The taper transitions the first wallthickness 550 disposed at the first sleeve end 532 to the second wallthickness 551 at the proximal end of the second portion 547. Thus, thefirst portion has a wall thickness that tapers from the first sleeve end532 to the proximal end of the second portion 547.

The second portion 547 is disposed between the first portion 546 and thethird portion 548 and extends along a second portion 555 of the axiallength 535 of sleeve 514. The second portion 547 extends from the distalend of the first portion 546 towards the second sleeve end 534 to theproximal end of the third portion 548. The second wall thickness 551 iscontinuous, or substantially continuous, along the second portion 555 ofthe axial length 535.

The third portion 548 is disposed between the second portion 547 and thefourth portion 549 and extends along extends along a third portion 556of the axial length 535 of sleeve 514. The third portion 548 extendsfrom the distal end of the second portion 547 towards the second sleeveend 534 to the proximal end of the fourth portion 549. The third portion548 defines an arc on the inner sleeve surface 540 and the outer sleevesurface 542. The third wall thickness 552 increases from the distal endof the second portion 547 to a point along the third portion 556 of theaxial length 535 and decreases from the same point, or a different,point, along the third portion 556 of the axial length 535 to theproximal end of the fourth portion 534.

The fourth portion 549 extends from the distal end of the third portion548 to the second sleeve end 534. The fourth portion 549 defines a taperon the inner sleeve surface 540 and the outer sleeve surface 542 thatextends along a fourth portion 557 of the axial length 535 of sleeve514. The taper transitions the wall thickness of the fourth portion 549from the wall thickness at the distal end of the third portion 548 tothe fourth wall thickness 553 at the second sleeve end 534. Thus, thefourth portion 549 has a wall thickness that tapers from the distal endof the third portion 548 to the second sleeve end 534.

In the illustrated embodiment, on any planar section orthogonal to thelengthwise axis of the sleeve 514, the wall thickness is constant, orsubstantially constant, around the entire circumferential length of thesleeve 514. Alternatively, as indicated above, the wall thickness canvary at one or more locations along the circumferential length and/oraxial length of a sleeve. Skilled artisans will be able to select asuitable wall thickness for a sleeve according to a particularembodiment based on various considerations, including the bodily passagewithin which the device is to be used.

FIG. 9 illustrates a sleeve 614 similar to sleeve 314 illustrated inFIG. 6, and described above, except as detailed below. Reference numbersin FIG. 9 refer to the same structural element or feature referenced bythe same number in FIG. 6, offset by 400. Thus, sleeve 614 has a firstsleeve end 632, a second sleeve end 634, and an axial length 635 thatextends from the first sleeve end 632 to the second sleeve end 634. Thefirst sleeve end 632 defines a first end opening 636 and the secondsleeve end 634 defines a second end opening 638. The sleeve 614 has aninner sleeve surface 640 and an outer sleeve surface 642 and defines asleeve lumen 644 that extends from the first sleeve end 632 to thesecond sleeve end 634. Sleeve 614 is illustrated in the first sealed, orsubstantially sealed, configuration.

In the illustrated embodiment, sleeve 614 has a first portion 646 havinga first wall thickness 650, a second portion 647 having a second wallthickness 651, and a third portion 648 having a third wall thickness652. The second portion 647 is disposed between the first portion 646and the third portion 648. Each of the first wall thickness 650, secondwall thickness 651, and third wall thickness 652 extends from the innersleeve surface 640 to the outer sleeve surface 642.

The first portion 646 extends from the first sleeve end 632 towards thesecond sleeve end 634 to the proximal end of the second portion 647. Thefirst portion 646 defines a continuous, or substantially continuous,first wall thickness 650 that extends along a first portion 654 of theaxial length 635 of sleeve 614.

The second portion 647 extends from the distal end of the first portion646 towards the second sleeve end 634 to the proximal end of the thirdportion 648 along a second portion 655 of the axial length 635 of sleeve614. The second portion 647 defines a taper on the inner sleeve surface640 that extends along the second portion 655 of the axial length 635 ofsleeve 614. The wall thickness of the second portion 647 disposed at thedistal end of the first portion 646 transitions from first wallthickness 650 to the second wall thickness 651 at the proximal end ofthe third portion 648. Thus, the second portion 647 has a wall thicknessthat tapers from the distal end of the first portion 646 to the proximalend of the third portion 648.

The third portion 648 extends from the distal end of the second portion647 to the second sleeve end 634 along a third portion 656 of the axiallength of sleeve 614. The third portion 648 defines a taper on the innersleeve surface 640 that extends along the third portion 656 of the axiallength 635 of sleeve 614. The wall thickness of the third portion 648transitions from the second wall thickness 651 at the distal end of thesecond portion 647 to the third wall thickness 652 at the second sleeveend 634. Thus, the wall thickness of the third portion 648 tapers fromthe distal end of the second portion 647 to the second sleeve end 634.

In the illustrated embodiment, the wall thickness of sleeve 614decreases from the distal end of the first portion 646 to the secondsleeve end 634. This structural configuration is considered advantageousat least because it allows for sleeve 614 to maintain a second sealed,or substantially sealed, configuration, with the application of a loweramount of pressure as compared to a sleeve having a greater wallthickness at the second portion and/or third portion.

FIG. 10 illustrates a sleeve 714 similar to sleeve 414 illustrated inFIG. 7, and described above, except as detailed below. Reference numbersin FIG. 10 refer to the same structural element or feature referenced bythe same number in FIG. 7 offset by 300. Thus, sleeve 714 has a firstsleeve end 732, a second sleeve end 734, and an axial length 735 thatextends from the first sleeve end 732 to the second sleeve end 734. Thefirst sleeve end 732 defines a first end opening 736 and the secondsleeve end 734 defines a second end opening 738. The sleeve 714 has aninner sleeve surface 740 and an outer sleeve surface 742 and defines asleeve lumen 744 that extends from the first sleeve end 732 to thesecond sleeve end 734. Sleeve 714 is illustrated in the first sealed, orsubstantially sealed, configuration.

In the illustrated embodiment, sleeve 714 has a first portion 746 havinga first wall thickness 750 and a second portion 748 having a second wallthickness 752. Each of the first wall thickness 750 and second wallthickness 752 extends from the inner sleeve surface 740 to the outersleeve surface 742.

The first portion 746 extends from the first sleeve end 732 towards thesecond sleeve end 734 to the proximal end of the second portion 748. Thefirst portion 746 defines a continuous, or substantially continuous,first wall thickness 750 that extends along a first portion 754 of theaxial length 735.

The second portion 748 extends from the proximal end of the firstportion 746 to the sleeve second end 734 along a second portion 755 ofthe axial length 735 of sleeve 714. The second portion 748 defines acurve on the inner sleeve surface 740 such that the second wallthickness 752 increases from the distal end of the first portion 746 toa point along the second portion 755 of the axial length 735 anddecreases from the same point, or a different point, along the thirdportion 755 of the axial length 735 to the sleeve second end 734. Thus,the second wall thickness 752 is unevenly distributed along the secondportion 755 of the axial length of sleeve 714 such that at a first pointalong the second portion 755 of the axial length 735 the second portionhas a wall thickness having a first length and at a second, different,point along the second portion 755 of the axial length 735 the secondportion has a wall thickness having a second length, which is differentthan the first length.

This structural configuration is considered advantageous at leastbecause it provides a mechanism for positioning the location at which asleeve will invert upon the application of pressure and the amount ofsleeve capable of inversion. For example, this configuration isconsidered advantageous at least for use in intraluminal medical devicesin which a partially invertible sleeve is desired.

FIG. 11 illustrates a sleeve 814 similar to sleeve 314 illustrated inFIG. 6, and described above, except as detailed below. Reference numbersin FIG. 11 refer to the same structural element or feature referenced bythe same number in FIG. 6, offset by 500. Thus, sleeve 814 has a firstsleeve end 832, a second sleeve end 834, and an axial length 835 thatextends from the first sleeve end 832 to the second sleeve end 834. Thefirst sleeve end 832 defines a first end opening 836 and the secondsleeve end 834 defines a second end opening 838. The sleeve 814 has aninner sleeve surface 840 and an outer sleeve surface 842 and defines asleeve lumen 844 that extends from the first sleeve end 832 to thesecond sleeve end 834. Sleeve 814 is illustrated in the first sealed, orsubstantially sealed, configuration.

In the illustrated embodiment, sleeve 814 has a first portion 846 havinga first wall thickness 850, a second portion 847 having a second wallthickness 851, and a third portion 848 having a third wall thickness852. The second portion 847 is disposed between the first portion 846and the third portion 848. Each of the first wall thickness 850, secondwall thickness 851, and third wall thickness 852 extends from the innersleeve surface 840 to the outer sleeve surface 842.

The first portion 846 extends from the first sleeve end 832 towards thesecond sleeve end 834 to the proximal end of the second portion 847. Thefirst portion 846 defines a continuous, or substantially continuous,first wall thickness 850 that extends along a first portion 854 of theaxial length 835 of sleeve 814.

The second portion 847 extends from the distal end of the first portion846 to the proximal end of the third portion 848 along a second portion855 of the axial length 835 of sleeve 814. The second portion 847defines a curve on the inner sleeve surface 840 such that the secondwall thickness 851 increases from the distal end of the first portion846 to a point along the second portion 855 of the axial length 835 anddecreases from the same point, or a different point, along the secondportion 855 of the axial length 835 to the proximal end of the thirdportion 848. Thus, the second wall thickness 851 between the distal endof the first portion 846 and the proximal end of the third portion 848is greater than the first wall thickness 850 and third wall thickness852.

The third portion 848 extends from the distal end of the second portion847 to the second sleeve end 834. The third portion 848 defines acontinuous, or substantially continuous, third wall thickness 852 thatextends along a third portion 856 of the axial length 835 of sleeve 814.

This structural configuration is considered advantageous at leastbecause it provides a mechanism for positioning the location at which asleeve will invert upon the application of pressure and the amount ofsleeve capable of inversion. For example, the distal end of the secondportion can be positioned as desired to control the length of sleevethat inverts into a frame. For example, this configuration is consideredadvantageous at least for use in intraluminal medical devices in which apartially invertible sleeve is desired.

FIG. 12 illustrates a sleeve 914 similar to sleeve 714 illustrated inFIG. 10, and described above, except as detailed below. Referencenumbers in FIG. 12 refer to the same structural element or featurereferenced by the same number in FIG. 10 offset by 200. Thus, sleeve 914has a first sleeve end 932, a second sleeve end 934, and an axial length935 that extends from the first sleeve end 932 to the second sleeve end934. The first sleeve end 932 defines a first end opening 936 and thesecond sleeve end 934 defines a second end opening 938. The sleeve 914has an inner sleeve surface 940 and an outer sleeve surface 942 anddefines a sleeve lumen 944 that extends from the first sleeve end 932 tothe second sleeve end 934. Sleeve 914 is illustrated in the firstsealed, or substantially sealed, configuration.

In the illustrated embodiment, sleeve 914 has a first portion 946 havinga first wall thickness 950 and a second portion 948 having a second wallthickness 952. Each of the first wall thickness 950 and second wallthickness 952 extends from the inner sleeve surface 940 to the outersleeve surface 942.

The first portion 946 extends from the first sleeve end 932 towards thesecond sleeve end 934 to the proximal end of the second portion 948. Thefirst portion 946 defines a continuous, or substantially continuous,first wall thickness 950 that extends along a first portion 954 of theaxial length 935.

The second portion 948 extends from the distal end of the first portion946 to the sleeve second end 934 along a second portion 955 of the axiallength 935 of sleeve 914. The second portion 948 defines a taper on theinner sleeve surface 940 that extends along the second portion 955 ofthe axial length 935 of sleeve 914. The wall thickness of the secondportion 948 increases from the first wall thickness 950 at the distalend of the first portion 946 to the second wall thickness 952 at thesecond sleeve end 934. Thus, the second portion 948 has a wall thicknessthat tapers from the second sleeve end 934 to the distal end of thefirst portion 946.

FIGS. 13 and 13A illustrate a sleeve 1014 similar to sleeve 314illustrated in FIG. 6, and described above, except as detailed below.Reference numbers in FIGS. 13 and 13A refer to the same structuralelement or feature referenced by the same number in FIG. 6, offset by700. Thus, sleeve 1014 has a first sleeve end 1032, a second sleeve end1034, and an axial length 1035 that extends from the first sleeve end1032 to the second sleeve end 1034. The first sleeve end 1032 defines afirst end opening 1036 and the second sleeve end 1034 defines a secondend opening 1038. The sleeve 1014 has an inner sleeve surface 1040 andan outer sleeve surface 1042 and defines a sleeve lumen 1044 thatextends from the first sleeve end 1032 to the second sleeve end 1034.Sleeve 1014 is illustrated in the first sealed, or substantially sealed,configuration. While FIGS. 13 and 13A illustrate an intraluminal medicaldevice according to a particular embodiment, it is understood that asleeve in a particular embodiment can have any suitable size, shape andconfiguration.

In the illustrated embodiment, sleeve 1014 has a first portion 1046having a first wall thickness 1050, a second portion 1047 having asecond wall thickness 1051, and a third portion 1048 having a third wallthickness 1052. The second portion 1047 is disposed between the firstportion 1046 and the third portion 1048. Each of the first wallthickness 1050, second wall thickness 1051, and third wall thickness1052 extends from the inner sleeve surface 1040 to the outer sleevesurface 1042. Each of the first wall thickness 1050, second wallthickness 1051, and third wall thickness 1052 has a continuous, orsubstantially continuous, wall thickness.

In the illustrated embodiment, the first portion 1046 extends from thefirst sleeve end 1032 towards the second sleeve end 1034 to the proximalend of the second portion 1047 along a first portion 1054 of the axiallength 1035 of sleeve 1014. First portion 1046 defines a first set ofrecesses 1058 that extend from the inner sleeve surface 1040 into thewall of the sleeve 1014 and a second set of recesses 1060 that extendfrom the outer sleeve surface 1042 and into the wall of the sleeve 1014.In the illustrated embodiment, each recess of the first set of recesses1058 and the second set of recesses 1060 has a diamond-shaped perimeter.It is considered advantageous to include one or more recesses on theinner sleeve surface and/or outer sleeve surface of the first portion ofa sleeve at least because this configuration reduces the pressurenecessary to move the sleeve from the extended position to the invertedposition, and vice versa, as compared to a sleeve that omits theinclusion of one or more recesses on a first portion.

Each recess of the first set of recesses 1058 and second set of recesses1060 can be formed using any suitable technique and/or method, andskilled artisans will be able to select a suitable technique and/ormethod to form a recess on a sleeve based on various considerations,including the desired flexibility of the sleeve. Example methods offorming a recess include, but are not limited to, cutting and removing aportion of the wall of a sleeve, or forming a sleeve and omitting thematerial where a recess is desired to be positioned.

While each recess of the first set of recesses 1058 and the second setof recesses 1060 has been described as having a diamond-shapedperimeter, a recess can have any suitable shape and skilled artisanswill be able to select a suitable shape for a recess of a sleeveaccording to a particular embodiment based on various considerations.Example shapes considered suitable for a recess include, but are notlimited to, circular, rectangular, triangular, faceted, curved, oval,oblong, and any other shape considered suitable for a particularapplication.

While three recesses have been illustrated on the inner sleeve surface1040 and the outer sleeve surface 1042, any suitable number of recesscan be included in a sleeve, and skilled artisans will be able to selecta suitable number of recesses for a sleeve according to a particularembodiment based on various considerations, including the desiredflexibility of the sleeve. Example number of recesses consideredsuitable for inclusion on an inner sleeve surface and/or an outer sleevesurface include, but are not limited to, one, two, three, four, five,six, seven, eight, nine, ten, a plurality, and any other numberconsidered suitable for a particular application.

While each recess of the first set of recesses 1058 and the second setof recesses 1060 has been illustrated and described as defined on thefirst portion of sleeve 1014, a recess, or a plurality of recesses, canbe defined on any suitable portion of a sleeve. Skilled artisans will beable to select a suitable portion of a sleeve to include one or morerecesses according to a particular embodiment based on variousconsiderations, including the desired flexibility of the sleeve. Exampleportions of a sleeve considered suitable to include one or more recessesinclude, but are not limited to, a portion that extends from a sleevefirst end towards a sleeve second end, a portion that extends from afirst point between a sleeve first end and a sleeve second end to asecond point distal to the first point and between the sleeve first endand the sleeve second end, and a portion that extends from a sleevesecond end towards a sleeve first end.

While various structural arrangements have been described for a sleevefor inclusion in an intraluminal medical device, various otherstructural arrangements are considered suitable. Skilled artisans willbe able to select a suitable structural arrangement for a sleeveaccording to a particular embodiment based on various considerations,including the desired pressure at which a sleeve moves from an expandedposition to an inverted position, and vice versa. Example structuralarrangements considered suitable include, but are not limited to, asleeve having the entirety, or a portion, of the axial length of thesleeve defining a taper, a sleeve having the entirety, or a portion, ofthe axial length of the sleeve defining a curve, a sleeve having theentirety, or a portion, of the axial length of the sleeve defining oneor more curves, a sleeve having the entirety, or a portion, of the axiallength of the sleeve defining an arc, a sleeve having the entirety, or aportion, of the axial length of the sleeve defining one or more arcs,and/or a sleeve having a wall that defines one or more shoulders alongthe axial length of the sleeve.

Any of the herein described structural configurations and/or features ofa sleeve can be combined in any suitable manner, and skilled artisanswill be able to select suitable structural configurations and/orfeatures to include in a sleeve according to a particular embodimentbased on various considerations, including the desired pressure at whicha sleeve moves from an expanded position to an inverted position.Example structural arrangements and/or features considered suitable forinclusion in a sleeve include, but are not limited to, those describedand/or illustrated with respect to sleeve 14, sleeve 114, sleeve 214,sleeve 314, sleeve 414, sleeve 514, sleeve 614, sleeve 714, sleeve 814,sleeve 914, and sleeve 1014.

FIGS. 14, 15, and 16 illustrate a fourth exemplary intraluminal medicaldevice 1110. The intraluminal medical device 1110 is similar to theintraluminal medical device 10 illustrated in FIGS. 1, 1A, 1B, 1C, and 2and described above, except as detailed below. Reference numbers inFIGS. 14, 15, and 16 refer to the same structural element or featurereferenced by the same number in FIGS. 1, 1A, 1B, 1C, and 2, offset by1100. Thus, the intraluminal medical device 1110 comprises a frame 1112and a sleeve 1114 attached to the frame 1112. The frame 1112 and sleeve1114 cooperatively define a device lumen 1116 that extends through thelength of the intraluminal medical device 1110. Frame 1112 has beenillustrated omitting the wire mesh, the plurality of intersecting wireportions, and the plurality of mesh openings for clarity. As describedherein, frame can have any suitable structural configuration and beformed of any suitable material.

In the illustrated embodiment, frame 1112 has a lengthwise axis 1113, afirst frame end 1118, and a second frame end 1120. The first frame end1118 defines a first frame end opening 1122 and the second frame end1120 defines a second frame end opening 1124. The frame 1112 has innerframe surface 1126 and an outer frame surface 1128 and defines a framelumen 1130 that extends from the first frame end 1118 to the secondframe end 1120. The frame 1112 defines a first shoulder 1162 and a firstflange 1164 disposed at the proximal end of the frame 1112 and a secondshoulder 1166 and a second flange 1168 disposed at the distal end of theframe 1112.

It is considered advantageous to include a first flange 1164 and asecond flange 1168 at least because this structural configurationprovides a mechanism for maintaining the position of the intraluminalmedical device 1110 in a bodily passage (e.g., esophagus) when deployed.

Sleeve 1114 has first sleeve end 1132 that defines a first end opening1136 and a second sleeve end 1134 defines a second end opening 1138.Second sleeve end 1134 is adapted to have a first configuration, asillustrated in FIGS. 14, 15, and 16, and a second configuration, notshown. In the first configuration, second end opening 1138 is sealed, orsubstantially sealed, along a portion, or the entirety, of thecircumferential length of sleeve 1114 such that materials and/or fluidsare prevented from passing through the second end opening 1138. In thesecond configuration, second end opening 1138 is open such thatmaterials and/or fluid can pass through the second end opening 1138.

In the illustrated embodiment, various sleeve attachment locations 1170,1172, 1174, and 1176 are illustrated and disposed along the length offrame 1112. Each sleeve attachment location 1170, 1172, 1174, and 1176is orthogonal to the lengthwise axis 1113 of frame 1112 and extendsabout a portion, or the entirety, of the circumferential length of frame1112. Sleeve attachment location 1170 is disposed at the second frameend 1120. Sleeve attachment location 1172 is disposed proximal to secondframe end 1120 and distal to second shoulder 1166. Thus, sleeveattachment location 1172 is disposed between second shoulder 1166 andsecond frame end 1120. Sleeve attachment location 1174 is disposed onsecond shoulder 1166 and sleeve attachment location 1176 is disposedbetween first frame end 1118 and second shoulder 1166. Frame 1112 has adifferent radial strength at each sleeve attachment location 1170, 1172,1174, and 1176. For example, the radial strength of frame 1112 at sleeveattachment location 1176 is greater than the radial strength of frame1112 at sleeve attachment location 1174. In addition, the radialstrength of frame 1112 at sleeve attachment location 1174 is greaterthan the radial strength of frame 1112 at sleeve attachment location1172. Furthermore, the radial strength of frame 1112 at sleeveattachment location 1172 is greater than the radial strength of frame1112 at sleeve attachment location 1170.

In the illustrated embodiment, first sleeve end 1132 is attached toinner frame surface 1126 at sleeve attachment location 1172 along aportion, or the entirety, of the circumferential length of frame 1112.Thus, first sleeve end 1132 is attached to frame 1112 between the secondshoulder 1166 and the second frame end 1120.

FIG. 14 shows sleeve 1114 in an extended position. As shown in FIG. 15,as pressure is applied via a material and/or fluid to sleeve 1114 in afirst direction, shown as arrows 1178, sleeve 1114 moves from theextended position to an inverted position, as shown in FIG. 16. Aspressure is applied via a material and/or fluid to sleeve 1114 in asecond direction, shown as arrows 1179, opposite, or substantiallyopposite, the first direction 1178, sleeve 1114 moves from the invertedposition to the extended position.

While attachment locations 1170, 1172, 1174, and 1176 have beendescribed as orthogonal to the lengthwise axis 1113 of frame 1112, it isconsidered suitable to attach a sleeve at any suitable angle to thelengthwise axis of a frame. Skilled artisans will be able to select asuitable angle to attach a sleeve to a frame according to a particularembodiment based on various considerations, including the desiredpressure at which the sleeve is intended to invert and/or revert.Example angles considered suitable to attach a sleeve on a frameinclude, but are not limited to, orthogonal to the lengthwise axis ofthe frame, at an angle between about 1 degree and about 179 degreesrelative to the lengthwise axis of the frame, and at any other angleconsidered suitable for a particular application.

While sleeve 1114 has been described and illustrated as attached to theinner frame surface 1126 at sleeve attachment location 1170, a sleevecan be attached to any suitable surface on a frame and at any suitablelocation along the axial length of a frame. Skilled artisans will beable to select a suitable surface on a frame and a suitable location ona frame to attach a sleeve according to a particular embodiment based onvarious considerations, including the materials forming the frame andthe sleeve. Example surfaces considered suitable to attach a sleeve to aframe include, but are not, limited to, an inner frame surface, and anouter frame surface. Alternatively, a sleeve can be formed on, or aspart of, the frame, as described in more detail herein. Examplelocations considered suitable to attach a sleeve include, but are notlimited to, attachment location 1170, attachment location 1172,attachment location 1174, attachment location 1176, at should 1162, atflange 1164, at shoulder 1166, at flange 1168, at sleeve first end 1118,and any other location along the axial length of a frame consideredsuitable for a particular application.

FIG. 17 illustrates a fifth exemplary intraluminal medical device 1210.The intraluminal medical device 1210 is similar to the intraluminalmedical device 1110 illustrated in FIGS. 14, 15, and 16 and describedabove, except as detailed below. Reference numbers in FIG. 17 refer tothe same structural element or feature referenced by the same number inFIGS. 14, 15, and 16, offset by 100. Thus, the intraluminal medicaldevice 1210 comprises a frame 1212 and a sleeve 1214 attached to theframe 1212. The frame 1212 and sleeve 1214 cooperatively define a devicelumen 1216 that extends through the length of the intraluminal medicaldevice 1210.

In the illustrated embodiment, sleeve 1214 is attached to frame 1112 atsleeve attachment location 1270, which is disposed at frame second end1220. Frame second end 1220 is adapted to move from a firstconfiguration (e.g., shown in FIG. 16) to a second configuration, shownin FIG. 17 in which frame second end 1220 moves radially inward (e.g.,collapses inward) into frame lumen 1230. Frame second end 1220 movesradially inward in response to a first pressure, shown as arrows 1280,being applied to intraluminal medical device 1210. First pressure isless than a second pressure, shown as arrows 1281, required to movesleeve 1214 from the extended position to the inverted position. Thisstructural arrangement is considered advantageous at least because itprevents sleeve 1214 from moving to the inverted position and provides amechanism for preventing material and/or fluid from passing through theintraluminal medical device through sleeve 1214.

Frame second end 1220 can be adapted to move radially inward anysuitable length and at any suitable pressure, and skilled artisans willbe able to select a suitable length and a suitable pressure to adapt aframe second end to move radially inward according to a particularembodiment based on various considerations. In addition, frame 1212 canbe formed of any suitable material using any suitable method toaccomplish movement of frame second end 1220, and skilled artisans willbe able to select a suitable material and method to form a frameaccording to a particular embodiment based on various considerations.Example materials and methods considered suitable include, but are notlimited to, those described herein, forming a frame with a lower numberof wire portions along the axial length and/or circumferential length ofthe frame that is to be moveable radially inward as compared to thereminder of the axial length and/or circumferential length of the frame,and any other material and/or method considered suitable for aparticular application.

The foregoing detailed description provides exemplary embodiments of theinvention and includes the best mode for practicing the invention. Thedescription and illustration of embodiments is intended only to provideexamples of the invention, and not to limit the scope of the invention,or its protection, in any manner.

What is claimed is:
 1. An implantable medical device, comprising: anexpandable frame having a first frame end and a second frame end anddefining a frame lumen extending from the first frame end to the secondframe end; and a sleeve attached to the frame, the sleeve having a firstsleeve end, a second sleeve end, a wall, an inner surface, an outersurface, a first portion, a second portion, an axial length extendingfrom the first sleeve end to the second sleeve end, and defining asleeve lumen extending between the first sleeve end and the secondsleeve end, the first portion extending along a portion of the axiallength from the first sleeve end towards the second sleeve end, thefirst portion having a first wall thickness extending between the innersurface and the outer surface, the second portion disposed between thefirst portion and the second sleeve end and extending along a portion ofthe axial length from the first portion towards the second sleeve end,the second portion having a second wall thickness extending between theinner surface and the outer surface, the second sleeve end having athird wall thickness extending between the inner surface and the outersurface, the first wall thickness being different than the second wallthickness, the third wall thickness being less than the second wallthickness; wherein the sleeve is adapted to invert between an extendedposition in which the second sleeve end and a part of the first portionis disposed outside of the frame lumen and an inverted position in whichthe second sleeve end and the part of the first portion is disposedwithin the frame lumen.
 2. The implantable medical device of claim 1,wherein the sleeve has a circumferential length; and wherein the thirdwall thickness extends along the entire circumferential length of thesleeve.
 3. The implantable medical device of claim 1, wherein the sleevedefines a taper along a portion of the axial length of the sleeve. 4.The implantable medical device of claim 1, wherein the sleeve defines ataper along the entire axial length of the sleeve.
 5. The implantablemedical device of claim 1, wherein the sleeve has a circumferentiallength; and wherein the second wall thickness extends along the entirecircumferential length of the sleeve.
 6. The implantable medical deviceof claim 1, wherein the second wall thickness is greater than the firstwall thickness.
 7. The implantable medical device of claim 6, whereinthe sleeve has a circumferential length; and wherein the second wallthickness extends along the entire circumferential length of the sleeve.8. The implantable medical device of claim 6, wherein the second portiondefines a curve on the inner surface of the sleeve that extends into thesleeve lumen.
 9. The implantable medical device of claim 8, wherein thecurve extends from the first portion to the second sleeve end.
 10. Theimplantable medical device of claim 1, wherein the wall defines a recessthat extends from the inner surface of the sleeve and into the wall ofthe sleeve.
 11. The implantable medical device of claim 1, wherein thewall defines a recess that extends from the outer surface of the sleeveand into the wall of the sleeve.
 12. An implantable medical device,comprising: an expandable frame having a first frame end and a secondframe end and defining a frame lumen extending from the first frame endto the second frame end; and a sleeve attached to the frame, the sleevehaving a first sleeve end, a second sleeve end, a wall, an innersurface, an outer surface, a first portion, a second portion, acircumferential length, an axial length extending from the first sleeveend to the second sleeve end, and defining a sleeve lumen extendingbetween the first sleeve end and the second sleeve end, the firstportion extending along a portion of the axial length from the firstsleeve end towards the second sleeve end, the first portion having afirst wall thickness extending between the inner surface and the outersurface, the second portion disposed between the first portion and thesecond sleeve end and extending along a portion of the axial length fromthe first portion towards the second sleeve end, the second portionhaving a second wall thickness extending between the inner surface andthe outer surface, the second sleeve end having a third wall thicknessextending between the inner surface and the outer surface, the firstwall thickness being different than the second wall thickness, thesecond wall thickness extending along the entire circumferential lengthof the sleeve, the third wall thickness being less than the second wallthickness and extending along the entire circumferential length of thesleeve; wherein the sleeve is adapted to invert between an extendedposition in which the second sleeve end and a part of the first portionis disposed outside of the frame lumen and an inverted position in whichthe second sleeve end and the part of the first portion is disposedwithin the frame lumen.
 13. The implantable medical device of claim 12,wherein the sleeve defines a taper along a portion of the axial lengthof the sleeve.
 14. The implantable medical device of claim 12, whereinthe sleeve defines a taper along the entire axial length of the sleeve.15. The implantable medical device of claim 12, wherein the second wallthickness is greater than the first wall thickness.
 16. The implantablemedical device of claim 15, wherein the second portion defines a curveon the inner surface of the sleeve that extends into the sleeve lumen.17. The implantable medical device of claim 16, wherein the curveextends from the first portion to the second sleeve end.
 18. Theimplantable medical device of claim 12, wherein the wall defines arecess that extends from the inner surface of the sleeve and into thewall of the sleeve.
 19. The implantable medical device of claim 12,wherein the wall defines a recess that extends from the outer surface ofthe sleeve and into the wall of the sleeve.
 20. An implantable medicaldevice, comprising: an expandable frame having a first frame end and asecond frame end and defining a frame lumen extending from the firstframe end to the second frame end; and a sleeve attached to the frame,the sleeve having a first sleeve end, a second sleeve end, a wall, aninner surface, an outer surface, a first portion, a second portion, acircumferential length, an axial length extending from the first sleeveend to the second sleeve end, and defining a sleeve lumen extendingbetween the first sleeve end and the second sleeve end, the firstportion extending along a portion of the axial length from the firstsleeve end towards the second sleeve end, the first portion having afirst wall thickness extending between the inner surface and the outersurface, the second portion disposed between the first portion and thesecond sleeve end and extending along a portion of the axial length fromthe first portion towards the second sleeve end, the second portionhaving a second wall thickness extending between the inner surface andthe outer surface, the second sleeve end having a third wall thicknessextending between the inner surface and the outer surface, the firstwall thickness being different than the second wall thickness, thesecond wall thickness extending along the entire circumferential lengthof the sleeve, the third wall thickness being less than the second wallthickness and extending along the entire circumferential length of thesleeve, the wall defining a first recess extending from the innersurface of the sleeve and into the wall of the sleeve, the wall defininga second recess extending from the outer surface of the sleeve and intothe wall of the sleeve; wherein the sleeve is adapted to invert betweenan extended position in which the second sleeve end and a part of thefirst portion is disposed outside of the frame lumen and an invertedposition in which the second sleeve end and the part of the firstportion is disposed within the frame lumen.